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Trial Outcomes & Findings for Selinexor (KPT-330) in Older Patients With Relapsed AML (NCT NCT02088541)

NCT ID: NCT02088541

Last Updated: 2023-01-26

Results Overview

Overall survival was defined as the time (in days) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

317 participants

Primary outcome timeframe

Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks)

Results posted on

2023-01-26

Participant Flow

Participant milestones

Participant milestones
Measure
Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)
Participants under PV greater than or equal to (\>=) 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m\^2) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
Physician's Choice 1 (PV <5)
Participants under PV \< 5.0 (those who had one prior line of AML therapy) received Best Supportive Care (BSC) which included blood product transfusions, antimicrobials, growth factors as needed, and hydroxyurea.
Physician's Choice 2 (PV >=5)
Participants under PV\>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA)
Participants under protocol versions (PV) less than (\<) 5.0 (those who had one prior line of acute myeloid leukemia (AML) therapy), received oral selinexor tablets at a dose of approximately 55 mg/m\^2 (milligrams per square meter) (60 to 120 mg based on body surface area \[BSA\]) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
Selinexor 60 mg (PV <5) (Equivalent to 35 mg/m^2)
Participants under PV \< 5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a fixed dose of 60 mg (equivalent to 35 mg/m\^2), twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
Overall Study
STARTED
117
44
58
71
27
Overall Study
Safety Population
115
39
45
71
27
Overall Study
Intent-to-treat (ITT) Population
118
0
57
0
0
Overall Study
COMPLETED
0
0
0
0
0
Overall Study
NOT COMPLETED
117
44
58
71
27

Reasons for withdrawal

Reasons for withdrawal
Measure
Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)
Participants under PV greater than or equal to (\>=) 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m\^2) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
Physician's Choice 1 (PV <5)
Participants under PV \< 5.0 (those who had one prior line of AML therapy) received Best Supportive Care (BSC) which included blood product transfusions, antimicrobials, growth factors as needed, and hydroxyurea.
Physician's Choice 2 (PV >=5)
Participants under PV\>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA)
Participants under protocol versions (PV) less than (\<) 5.0 (those who had one prior line of acute myeloid leukemia (AML) therapy), received oral selinexor tablets at a dose of approximately 55 mg/m\^2 (milligrams per square meter) (60 to 120 mg based on body surface area \[BSA\]) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
Selinexor 60 mg (PV <5) (Equivalent to 35 mg/m^2)
Participants under PV \< 5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a fixed dose of 60 mg (equivalent to 35 mg/m\^2), twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
Overall Study
Adverse Event
3
3
0
3
0
Overall Study
Death
85
28
38
51
21
Overall Study
Lost to Follow-up
1
0
0
2
0
Overall Study
Physician Decision
2
0
2
2
1
Overall Study
Disease progression
2
3
1
7
1
Overall Study
Study terminated by sponsor
12
2
6
1
1
Overall Study
Withdrawal by Subject
9
7
10
3
2
Overall Study
Other
3
1
1
2
1

Baseline Characteristics

Selinexor (KPT-330) in Older Patients With Relapsed AML

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA)
n=71 Participants
Participants under PV \< 5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a dose of approximately 55 mg/m\^2 (60 to 120 mg based on BSA) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
Selinexor 60 mg (PV<5) (Equivalent to 35 mg/m^2)
n=27 Participants
Participants under PV \< 5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a fixed dose of 60 mg (equivalent to 35 mg/m\^2), based on BSA, twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)
n=115 Participants
Participants under PV \>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m\^2) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
Physician's Choice 1 (PV <5)
n=39 Participants
Participants under PV \< 5.0 (those who had one prior line of AML therapy) received Best Supportive Care (BSC) which included blood product transfusions, antimicrobials, growth factors as needed, and hydroxyurea.
Physician's Choice 2 (PV >=5)
n=45 Participants
Participants under PV\>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Total
n=297 Participants
Total of all reporting groups
Age, Continuous
72.4 years
STANDARD_DEVIATION 6.49 • n=5 Participants
73.2 years
STANDARD_DEVIATION 4.64 • n=7 Participants
73.6 years
STANDARD_DEVIATION 5.99 • n=5 Participants
72.6 years
STANDARD_DEVIATION 5.24 • n=4 Participants
74.2 years
STANDARD_DEVIATION 5.92 • n=21 Participants
73.2 years
STANDARD_DEVIATION 5.90 • n=10 Participants
Sex: Female, Male
Female
26 Participants
n=5 Participants
11 Participants
n=7 Participants
46 Participants
n=5 Participants
17 Participants
n=4 Participants
15 Participants
n=21 Participants
115 Participants
n=10 Participants
Sex: Female, Male
Male
45 Participants
n=5 Participants
16 Participants
n=7 Participants
69 Participants
n=5 Participants
22 Participants
n=4 Participants
30 Participants
n=21 Participants
182 Participants
n=10 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
n=5 Participants
3 Participants
n=7 Participants
9 Participants
n=5 Participants
4 Participants
n=4 Participants
6 Participants
n=21 Participants
26 Participants
n=10 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
65 Participants
n=5 Participants
23 Participants
n=7 Participants
93 Participants
n=5 Participants
34 Participants
n=4 Participants
31 Participants
n=21 Participants
246 Participants
n=10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
n=5 Participants
1 Participants
n=7 Participants
13 Participants
n=5 Participants
1 Participants
n=4 Participants
8 Participants
n=21 Participants
25 Participants
n=10 Participants
Race/Ethnicity, Customized
White
67 Count of Participants
n=5 Participants
22 Count of Participants
n=7 Participants
95 Count of Participants
n=5 Participants
39 Count of Participants
n=4 Participants
37 Count of Participants
n=21 Participants
260 Count of Participants
n=10 Participants
Race/Ethnicity, Customized
Black or African American
3 Count of Participants
n=5 Participants
1 Count of Participants
n=7 Participants
3 Count of Participants
n=5 Participants
0 Count of Participants
n=4 Participants
0 Count of Participants
n=21 Participants
7 Count of Participants
n=10 Participants
Race/Ethnicity, Customized
Asian
0 Count of Participants
n=5 Participants
2 Count of Participants
n=7 Participants
0 Count of Participants
n=5 Participants
0 Count of Participants
n=4 Participants
0 Count of Participants
n=21 Participants
2 Count of Participants
n=10 Participants
Race/Ethnicity, Customized
Other
0 Count of Participants
n=5 Participants
1 Count of Participants
n=7 Participants
15 Count of Participants
n=5 Participants
0 Count of Participants
n=4 Participants
6 Count of Participants
n=21 Participants
22 Count of Participants
n=10 Participants
Race/Ethnicity, Customized
Unknown
1 Count of Participants
n=5 Participants
1 Count of Participants
n=7 Participants
2 Count of Participants
n=5 Participants
0 Count of Participants
n=4 Participants
2 Count of Participants
n=21 Participants
6 Count of Participants
n=10 Participants

PRIMARY outcome

Timeframe: Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks)

Population: Intent-to-treat (ITT) population included all participants who were randomized to study treatment under PV\>=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV\>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV\>=5).

Overall survival was defined as the time (in days) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact.

Outcome measures

Outcome measures
Measure
Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)
n=118 Participants
Participants under PV \>=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m\^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).
Physician's Choice 2 (PV >=5)
n=57 Participants
Participants under PV \>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Overall Survival
94.0 Days
Interval 78.0 to 158.0
170.0 Days
Interval 111.0 to 220.0

SECONDARY outcome

Timeframe: From randomization (Day 1) up to 3 months

Population: ITT population included all participants who were randomized to study treatment under PV \>=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV\>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV\>=5).

Overall survival was defined as the time (in days) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure
Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)
n=118 Participants
Participants under PV \>=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m\^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).
Physician's Choice 2 (PV >=5)
n=57 Participants
Participants under PV \>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Percentage of Participants With Overall Survival of at Least 3 Months (OS3.0)
53.49 Percentage of participants
Interval 43.54 to 62.44
70.73 Percentage of participants
Interval 55.6 to 81.52

SECONDARY outcome

Timeframe: Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks)

Population: ITT population included all participants who were randomized to study treatment under PV\>=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV\>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV\>=5).

CRR was analyzed using International Working Group (IWG) 2003 criteria, as the difference in the proportions of participants with IWG results of CR. CR per IWG 2003 criteria was defined as morphologic presence of \< 5 percentage (%) myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood absolute neutrophil count (ANC) \> 1000 cells/microliter (microL) and platelet count \> 100,000/microL, with no need for red blood cell (RBC) transfusions), and the absence of extramedullary disease.

Outcome measures

Outcome measures
Measure
Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)
n=118 Participants
Participants under PV \>=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m\^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).
Physician's Choice 2 (PV >=5)
n=57 Participants
Participants under PV \>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Percentage of Participants With Complete Remission Rate (CRR) for Those Who Achieved Complete Remission (CR)
5.1 Percentage of participants
Interval 1.9 to 10.7
0 Percentage of participants
Interval 0.0 to 6.3

SECONDARY outcome

Timeframe: Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks)

Population: ITT population:all participants who randomized to study treatment under PV\>=5.0, regardless of whether or not they received study treatment. This outcome measure(OM) was only defined for CR participants. For Physician Choice 2,there was zero CR participants."Overall Number of Participants Analyzed (N)": Number of participants evaluable for this OM.

DFS for CRR based on IWG criteria, was calculated from the first date of response of CR to the date of progression or recurrence, or date of death if progression or recurrence did not occur. Participants who discontinued prior to disease progression or recurrence or did not progress as of the time of the analysis were censored at the time of last radiologic assessment. CR per IWG 2003 criteria was defined as morphologic presence of \< 5 % myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood ANC \> 1000 cells/microL and platelet count \> 100,000/microL, with no need for RBC transfusions), and the absence of extramedullary disease.

Outcome measures

Outcome measures
Measure
Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)
n=6 Participants
Participants under PV \>=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m\^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).
Physician's Choice 2 (PV >=5)
Participants under PV \>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Median Disease-Free Survival (DFS) for Participants Who Achieved Complete Remission (CR)
121.0 Days
Interval 49.0 to
Upper limits of 95% confidence Interval (CI) was not estimable due to less number of participants and events.
—

SECONDARY outcome

Timeframe: Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks)

Population: ITT population included all participants who were randomized to study treatment under PV\>=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV\>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV\>=5).

mCRR was defined as the point estimate of the percentage of participants who had CR, CRi, or CRp. Responses defined as per IWG 2003 response criteria: Morphologic CR:\< 5% myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood ANC \> 1000 cells/microL and platelet count \> 100,000/microL, with no need for RBC transfusions), and the absence of extramedullary disease. Morphologic CRp: All criteria for CR except for residual neutropenia (\<1x10\^9/L) or thrombocytopenia (\<100 x10\^9/L), Cri (\< 5% bone marrow blasts with residual neutropenia \[ANC \< 1000 cells/microL\] or thrombocytopenia \[platelets \< 100,000/microL\]), normal maturation of all cellular components in the bone marrow, no extramedullary disease and transfusion independent.

Outcome measures

Outcome measures
Measure
Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)
n=118 Participants
Participants under PV \>=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m\^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).
Physician's Choice 2 (PV >=5)
n=57 Participants
Participants under PV \>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Percentage of Participants With Modified Complete Remission Rate (mCRR) for Those Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematologic Recovery (Cri)
11.9 Percentage of participants
Interval 6.6 to 19.1
3.5 Percentage of participants
Interval 0.4 to 12.1

SECONDARY outcome

Timeframe: Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks)

Population: ITT population included all participants who were randomized to study treatment under PV \>=5.0, regardless of whether or not they received study treatment. Here, "N" signifies number of participants evaluable for this outcome measure.

DFS based on IWG criteria was defined as the duration from start of the complete response achieved until disease progression or death from any cause. Responses defined by IWG 2003 Response Criteria: Morphologic CR: \< 5% myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood ANC \> 1000 cells/microL and platelet count \> 100,000/microL, with no need for RBC transfusions), and the absence of extramedullary disease. Morphologic CRp: All criteria for CR except for residual neutropenia (\<1x10\^9/L) or thrombocytopenia (\<100 x10\^9/L), Cri (\< 5% bone marrow blasts with residual neutropenia \[ANC \< 1000 cells/microL\] or thrombocytopenia \[platelets \< 100,000/microL\]), normal maturation of all cellular components in the bone marrow, no extramedullary disease and transfusion independent.

Outcome measures

Outcome measures
Measure
Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)
n=14 Participants
Participants under PV \>=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m\^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).
Physician's Choice 2 (PV >=5)
n=2 Participants
Participants under PV \>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Median Disease-Free Survival (DFS) for Participants Who Achieved Complete Remission or CR With Incomplete Hematologic Recovery (CRi) or Complete Remission With Incomplete Platelet Recovery (CRp)
175.0 Days
Interval 61.0 to 288.0
106.0 Days
Upper and lower limits of 95% CI was not estimable due to the small number of participants and events.

SECONDARY outcome

Timeframe: Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks)

Population: ITT population included all participants who were randomized to study treatment under PV\>=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV\>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV\>=5).

Overall response rate was defined as the point estimate of the percentage of participants who achieved CR (disappearance of all target and non-target lesions), partial response (PR) (\>=30 % decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non-target lesions). CRi; \< 5% BM blasts with residual neutropenia \[ANC \< 1000 cells/microL\] or thrombocytopenia \[platelets \< 100,000/microL\]. CRp; All criteria for CR except for residual neutropenia (\<1x10\^9/L) or thrombocytopenia (\<100 x10\^9/L) and morphologic leukemia-free state (MLFS); morphologic BM blast clearance to \<5% in a marrow sample in which \<=200 cells enumerated or cellularity is ≥10%, in absence of blasts with Auer rods, no hematologic recovery required.

Outcome measures

Outcome measures
Measure
Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)
n=118 Participants
Participants under PV \>=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m\^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).
Physician's Choice 2 (PV >=5)
n=57 Participants
Participants under PV \>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Percentage of Participants With Overall Response Rate (ORR)
13.6 Percentage of participants
Interval 8.0 to 21.1
8.8 Percentage of participants
Interval 2.9 to 19.3

SECONDARY outcome

Timeframe: Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks)

Population: ITT population included all participants who were randomized to study treatment under PV\>=5.0, regardless of whether or not they received study treatment. Here, "N" signifies number of participants evaluable for this outcome measure.

DOR was calculated from date of response of CR, CRi, CRp, MLFS, or PR to date of progression or recurrence based on IWG criteria. CR: \<5% myeloblasts in bone marrow,absence of circulating blasts, hematologic recovery (peripheral blood ANC \>1000 cells/microL, platelet count \> 100,000/microL, no need for RBC transfusions), absence of extramedullary disease. PR: No circulating blasts, neutrophil count \> =1.0 x10\^9/L, platelet count \>= 100 x10\^9/L, \>= 50 % reduction in bone marrow blast to 6% to 25%, or blasts less than or equal to (\<=) 5% if Auer rods are present. CRp: All criteria for CR except for residual neutropenia (\<1x10\^9/L) or thrombocytopenia (\<100 x10\^9/L), CRi; \< 5% bone marrow blasts with residual neutropenia \[ANC \< 1000 cells/microL\] or thrombocytopenia \[platelets \< 100,000/microL\]. MLFS: morphologic bone marrow blast clearance to \< 5% in marrow sample, \<= 200 cells enumerated/cellularity is ≥ 10%, in absence of blasts with Auer rods, no hematologic recovery required.

Outcome measures

Outcome measures
Measure
Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)
n=16 Participants
Participants under PV \>=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m\^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).
Physician's Choice 2 (PV >=5)
n=5 Participants
Participants under PV \>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Duration of Response (DOR)
204.0 Days
Interval 117.0 to 334.0
148.0 Days
Interval 85.0 to
Upper limit of 95% CI was not estimated due to less number of participants and events.

SECONDARY outcome

Timeframe: Up to 4 weeks from the date of randomization to the date of progression or recurrence based on IWG criteria

Population: ITT Population included all participants who were randomized to study treatment under PV\>=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV\>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV\>=5).

DCR:Point estimate of % of participants with CR,CRi,CRp,MLFS,PR, or SD for \<=4 weeks.CR:\<5% myeloblasts in bone marrow (BM),absence of circulating blasts,hematologic recovery(peripheral blood ANC \>1000 cells/microL and platelet count \>100,000/microL, no need of RBC transfusions),absence of extramedullary disease. PR:No circulating blasts,Neutrophil count \>=1.0 x10\^9/L, Platelet count \>= 100\*10\^9/L, \>=50% reduction in BM blast to 6% to 25%, or blasts \<=5% if Auer rods are present.CRp:All criteria for CR except for residual neutropenia (\<1\*10\^9/L) or thrombocytopenia(\<100 x10\^9/L),CRi;\< 5% BM blasts with residual neutropenia \[ANC \< 1000 cells/microL\] or thrombocytopenia \[platelets \< 100,000/microL\]. MLFS:morphologic BM blast clearance to \<5% in a marrow sample in which \<=200 cells enumerated or cellularity is ≥10%,in absence of blasts with Auer rods,no hematologic recovery required,SD:failure to achieve a response but not meeting criteria for disease progression over period of \>4 weeks.

Outcome measures

Outcome measures
Measure
Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)
n=118 Participants
Participants under PV \>=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m\^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).
Physician's Choice 2 (PV >=5)
n=57 Participants
Participants under PV \>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Percentage of Participants With Disease Control Rate (DCR)
50.8 Percentage of participants
Interval 41.5 to 60.2
40.4 Percentage of participants
Interval 27.6 to 54.2

SECONDARY outcome

Timeframe: Up to 4 weeks from the date of randomization to the date of progression or recurrence based on IWG criteria

Population: ITT population included all participants who were randomized to study treatment under PV\>=5.0, regardless of whether or not they received study treatment. Here," N" signifies number of participants evaluable for this measure.

Duration of DCR calculated for all participants with DCR. CR: \< 5% myeloblasts in BM, absence of circulating blasts, hematologic recovery (peripheral blood ANC \>1000 cells/microL and platelet count \> 100,000/microL, no need for RBC transfusions), absence of extra medullary disease. PR: No circulating blasts, Neutrophil count \>=1.0 x 10\^9/L, Platelet count \>= 100 x 10\^9/L, \>= 50 % reduction in BM blast to 6% to 25%, or blasts \<= 5% if Auer rods are present. CRp: All criteria for CR except for residual neutropenia (\<1 x 10\^9/L) or thrombocytopenia (\<100 x 10\^9/L), CRi; \< 5% BM blasts with residual neutropenia \[ANC \< 1000 cells/microL\] or thrombocytopenia \[platelets \< 100,000/microL\]. MLFS; morphologic BM blast clearance to \< 5% in a marrow sample in which \<=200 cells enumerated/cellularity is \>= 10%, in absence of blasts with Auer rods, no hematologic recovery required and SD; failure to achieve a response but not meeting criteria for disease progression over period of \> 4 weeks.

Outcome measures

Outcome measures
Measure
Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)
n=60 Participants
Participants under PV \>=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m\^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).
Physician's Choice 2 (PV >=5)
n=23 Participants
Participants under PV \>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Duration of Disease Control Rate
187.0 Days
Interval 125.0 to 261.0
233.0 Days
Interval 155.0 to 263.0

SECONDARY outcome

Timeframe: Baseline, Day 1 of each treatment cycle (a maximum of 20 cycles: 28 days per cycle) up to 30 days after last dose of study drug (final visit)

Population: Per-Protocol (PP) population: all participants randomized to study treatment under PV\>=5.0 who received any amount of study treatment and had no major protocol violations that compromised assessment of efficacy. Here, N= number of participants evaluable for this measure and n=participants evaluable for this outcome measure at specified categories.

QoL was assessed by the FACT-Leu. FACT-Leu combines the General version of the Functional Assessment of Cancer Therapy (FACT-G) with a leukemia-specific sub-scale (17 items). The sub-scales for the FACT-G are Physical Well-Being (7 items), Social/Family Well-Being (7 items), Emotional Well-Being (6 items), and Functional Well-Being (7 items). The trial outcomes index (TOI; total of 31 items) was the primary measurement of interest, comprising the Physical and Functional sub-scales plus the leukemia - specific sub-scale. Each item was rated on a 5-point Likert scale. Range from 0 = (Not at all) to 4 = (Very much); therefore, the TOI had a score ranging from 0 to 124. Higher scores indicated improvement in well being. The QoL assessment was performed at baseline (prior to first dose of study treatment), Day 1 of each cycle on or after the second, and at the final visit.

Outcome measures

Outcome measures
Measure
Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)
n=71 Participants
Participants under PV \>=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m\^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).
Physician's Choice 2 (PV >=5)
n=34 Participants
Participants under PV \>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu]
Baseline
70.5 Units on a scale
Standard Deviation 15.20
75.4 Units on a scale
Standard Deviation 14.74
Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu]
C2D1
0.5 Units on a scale
Standard Deviation 16.50
-1.9 Units on a scale
Standard Deviation 15.18
Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu]
C3D1
-1.9 Units on a scale
Standard Deviation 16.88
-5.4 Units on a scale
Standard Deviation 22.25
Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu]
C4D1
-1.2 Units on a scale
Standard Deviation 15.70
-7.4 Units on a scale
Standard Deviation 25.41
Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu]
C5D1
-2.4 Units on a scale
Standard Deviation 16.84
1.9 Units on a scale
Standard Deviation 8.40
Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu]
C6D1
-3.4 Units on a scale
Standard Deviation 15.66
-4.7 Units on a scale
Standard Deviation 13.20
Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu]
C7D1
-5.0 Units on a scale
Standard Deviation 17.21
-11.8 Units on a scale
Standard Deviation 27.43
Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu]
C8D1
-3.9 Units on a scale
Standard Deviation 15.78
-10.6 Units on a scale
Standard Deviation 7.83
Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu]
C9D1
-2.7 Units on a scale
Standard Deviation 7.47
-8.0 Units on a scale
Standard Deviation 8.49
Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu]
C10D1
2.4 Units on a scale
Standard Deviation 13.19
-10.7 Units on a scale
Standard Deviation 12.70
Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu]
C11D1
-0.1 Units on a scale
Standard Deviation 8.65
-10.0 Units on a scale
Standard Deviation 9.90
Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu]
C12D1
-3.7 Units on a scale
Standard Deviation 11.69
-7.0 Units on a scale
Standard Deviation 16.97
Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu]
C13D1
-3.3 Units on a scale
Standard Deviation 6.40
-9.0 Units on a scale
Standard Deviation NA
Standard Deviation was not estimated due to less number of participants.
Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu]
C14D1
-4.0 Units on a scale
Standard Deviation 3.46
-15.0 Units on a scale
Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu]
C15D1
1.5 Units on a scale
Standard Deviation 3.54
-10.0 Units on a scale
Standard Deviation NA
Standard Deviation was not estimated due to less number of participants.
Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu]
C16D1
—
-15.0 Units on a scale
Standard Deviation NA
Standard Deviation was not estimated due to less number of participants.
Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu]
C17D1
-15.0 Units on a scale
Standard Deviation NA
Standard Deviation was not estimated due to less number of participants.
-7.0 Units on a scale
Standard Deviation NA
Standard Deviation was not estimated due to less number of participants.
Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu]
C18D1
-1.0 Units on a scale
Standard Deviation NA
Standard Deviation was not estimated due to less number of participants.
—
Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu]
C19D1
-12.0 Units on a scale
Standard Deviation NA
Standard Deviation was not estimated due to less number of participants.
—
Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu]
C20D1
-14.0 Units on a scale
Standard Deviation NA
Standard Deviation was not estimated due to less number of participants.
—
Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu]
Final visit
2.5 Units on a scale
Standard Deviation 17.71
-1.7 Units on a scale
Standard Deviation 20.46

SECONDARY outcome

Timeframe: Baseline, Day 1 of each treatment cycle (a maximum of 20 cycles: 28 days per cycle) up to 30 days after last dose of study drug (final visit)

Population: PP Population included all participants randomized to study treatment under PV \>=5.0 who received any amount of study treatment and who had no major protocol violations that compromised assessment of efficacy. Here, N= number of participants evaluable for this measure and n =Participants evaluable for this outcome measure at specified categories

EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D-5-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.

Outcome measures

Outcome measures
Measure
Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)
n=71 Participants
Participants under PV \>=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m\^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).
Physician's Choice 2 (PV >=5)
n=34 Participants
Participants under PV \>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS)
Baseline
67.9 Units on a scale
Standard Deviation 19.51
63.5 Units on a scale
Standard Deviation 21.10
Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS)
C2D1
-7.5 Units on a scale
Standard Deviation 23.45
0.8 Units on a scale
Standard Deviation 15.82
Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS)
C3D1
-13.3 Units on a scale
Standard Deviation 25.04
-5.2 Units on a scale
Standard Deviation 23.54
Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS)
C4D1
-6.1 Units on a scale
Standard Deviation 20.80
-5.0 Units on a scale
Standard Deviation 11.46
Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS)
C5D1
-0.9 Units on a scale
Standard Deviation 20.83
-2.0 Units on a scale
Standard Deviation 15.31
Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS)
C6D1
-11.2 Units on a scale
Standard Deviation 25.90
-1.4 Units on a scale
Standard Deviation 24.10
Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS)
C7D1
-3.7 Units on a scale
Standard Deviation 23.91
4.0 Units on a scale
Standard Deviation 10.84
Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS)
C8D1
0.1 Units on a scale
Standard Deviation 16.77
5.0 Units on a scale
Standard Deviation 9.35
Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS)
C9D1
4.6 Units on a scale
Standard Deviation 13.25
5.0 Units on a scale
Standard Deviation 10.80
Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS)
C10D1
0.7 Units on a scale
Standard Deviation 18.58
6.3 Units on a scale
Standard Deviation 15.48
Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS)
C11D1
0.8 Units on a scale
Standard Deviation 18.55
-5.0 Units on a scale
Standard Deviation 21.21
Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS)
C12D1
3.3 Units on a scale
Standard Deviation 16.63
-5.0 Units on a scale
Standard Deviation 28.28
Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS)
C13D1
6.7 Units on a scale
Standard Deviation 20.21
10.0 Units on a scale
Standard Deviation NA
Standard Deviation was not estimated due to less number of participants.
Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS)
C14D1
6.7 Units on a scale
Standard Deviation 25.66
15.0 Units on a scale
Standard Deviation NA
Standard Deviation was not estimated due to less number of participants.
Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS)
C15D1
3.5 Units on a scale
Standard Deviation 30.41
-10.0 Units on a scale
Standard Deviation NA
Standard Deviation was not estimated due to less number of participants.
Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS)
C16D1
—
20.0 Units on a scale
Standard Deviation NA
Standard Deviation was not estimated due to less number of participants.
Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS)
C17D1
25.0 Units on a scale
Standard Deviation NA
Standard Deviation was not estimated due to less number of participants.
-5.0 Units on a scale
Standard Deviation NA
Standard Deviation was not estimated due to less number of participants.
Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS)
C18D1
25.0 Units on a scale
Standard Deviation NA
Standard Deviation was not estimated due to less number of participants.
—
Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS)
C19D1
30.0 Units on a scale
Standard Deviation NA
Standard Deviation was not estimated due to less number of participants.
—
Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS)
C20D1
35.0 Units on a scale
Standard Deviation NA
Standard Deviation was not estimated due to less number of participants.
—

Adverse Events

Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA)

Serious events: 58 serious events
Other events: 71 other events
Deaths: 24 deaths

Selinexor 60mg (PV<5) (Equivalent to 35 mg/m^2)

Serious events: 15 serious events
Other events: 27 other events
Deaths: 3 deaths

Selinexor 60mg (PV >=5) (Equivalent to 35 mg/m^2)

Serious events: 89 serious events
Other events: 113 other events
Deaths: 28 deaths

Physician's Choice 1 (PV <5)

Serious events: 25 serious events
Other events: 37 other events
Deaths: 7 deaths

Physician's Choice 2 (PV >=5)

Serious events: 30 serious events
Other events: 40 other events
Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure
Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA)
n=71 participants at risk
Participants under PV \<5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a dose of approximately 55 mg/m\^2 (60 to 120 mg based on BSA) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
Selinexor 60mg (PV<5) (Equivalent to 35 mg/m^2)
n=27 participants at risk
Participants under PV \<5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a fixed dose of 60 mg (equivalent to 35 mg/m\^2), based on BSA, twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
Selinexor 60mg (PV >=5) (Equivalent to 35 mg/m^2)
n=115 participants at risk
Participants under PV \>=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m\^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).
Physician's Choice 1 (PV <5)
n=39 participants at risk
Participants under PV \< 5.0 (those who had one prior line of AML therapy) received Best Supportive Care (BSC) which included blood product transfusions, antimicrobials, growth factors as needed, and hydroxyurea.
Physician's Choice 2 (PV >=5)
n=45 participants at risk
Participants under PV \>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Blood and lymphatic system disorders
Anaemia
2.8%
2/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.7%
3/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Blood and lymphatic system disorders
Febrile Neutropenia
22.5%
16/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
14.8%
4/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
17.4%
20/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
20.5%
8/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
35.6%
16/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Blood and lymphatic system disorders
Leukostasis Syndrome
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Blood and lymphatic system disorders
Neutropenia
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Blood and lymphatic system disorders
Splenic Infarction
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Blood and lymphatic system disorders
Thrombocytopenia
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Acute Coronary Syndrome
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Atrial Fibrillation
2.8%
2/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Bradycardia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Cardiac Failure
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Cardiac Failure Congestive
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Cardio-Respiratory Arrest
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Sinus Bradycardia
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Tachyarrhythmia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Ventricular Fibrillation
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Ear and labyrinth disorders
Vertigo
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Eye disorders
Cataract
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Abdominal Pain Upper
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Constipation
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Diarrhoea
4.2%
3/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.2%
6/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Diverticular Perforation
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Gastrointestinal Haemorrhage
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Large Intestinal Haemorrhage
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Mouth Ulceration
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Nausea
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Tooth Loss
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Vomiting
5.6%
4/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Asthenia
4.2%
3/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Condition Aggravated
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
General Physical Health Deterioration
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Malaise
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Multiple Organ Dysfunction Syndrome
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Pain
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Pyrexia
5.6%
4/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.1%
7/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Hepatobiliary disorders
Cholecystitis Acute
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Hepatobiliary disorders
Hyperbilirubinaemia
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Arthritis Bacterial
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Aspergillus Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Biliary Sepsis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Biliary Tract Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Cellulitis
2.8%
2/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Clostridium Difficile Infection
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Device Related Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Diverticulitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Escherichia Sepsis
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Fungal Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Klebsiella Sepsis
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Laryngitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Lower Respiratory Tract Infection
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Lung Infection
4.2%
3/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.7%
3/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Necrotising Fasciitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Neutropenic Sepsis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Penile Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Perirectal Abscess
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Pneumocystis Jirovecii Pneumonia
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Pneumonia
14.1%
10/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
14.8%
4/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
8.7%
10/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
10.3%
4/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.7%
3/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Pneumonia Fungal
2.8%
2/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Sepsis
11.3%
8/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.7%
3/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Septic Shock
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Sialoadenitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Sinusitis
2.8%
2/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Skin Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Soft Tissue Infection
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Tonsillitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Upper Respiratory Tract Infection
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Urinary Tract Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Urosepsis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Vaginal Abscess
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Vulval Cellulitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Fall
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Femur Fracture
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Subarachnoid Haemorrhage
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Subdural Haematoma
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Subdural Haemorrhage
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Blood Alkaline Phosphatase Increased
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
C-Reactive Protein Increased
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Electrocardiogram Change
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Enterococcus Test Positive
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Troponin T Increased
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Vitamin B12 Decreased
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Weight Decreased
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Decreased Appetite
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.2%
6/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Dehydration
7.0%
5/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Failure To Thrive
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Fluid Overload
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hypercreatininaemia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hyperglycaemia
7.0%
5/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hyperkalaemia
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hyponatraemia
4.2%
3/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hypophagia
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Bone Pain
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Muscular Weakness
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebellar Tumour
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Ataxia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Cerebral Haemorrhage
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Cerebral Infarction
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Cerebrovascular Accident
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Dizziness
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Embolic Stroke
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Encephalopathy
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Haemorrhage Intracranial
2.8%
2/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Haemorrhagic Cerebral Infarction
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Headache
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Ischaemic Stroke
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Loss Of Consciousness
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Nervous System Disorders
11.3%
8/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
13.0%
15/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Presyncope
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Syncope
2.8%
2/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Psychiatric disorders
Confusional State
5.6%
4/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Psychiatric disorders
Hallucination
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Psychiatric disorders
Mental Status Changes
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Psychiatric disorders
Organic Brain Syndrome
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Acute Kidney Injury
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Oliguria
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Renal Failure
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Reproductive system and breast disorders
Vaginal Haemorrhage
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
2.8%
2/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Epistaxis
2.8%
2/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
2.8%
2/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
2.8%
2/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Social circumstances
Social Stay Hospitalisation
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Aortic Aneurysm
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Haematoma
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Hypotension
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.5%
4/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Peripheral Ischaemia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Thrombophlebitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Venous Thrombosis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Fatigue
1.4%
1/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.0%
8/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.

Other adverse events

Other adverse events
Measure
Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA)
n=71 participants at risk
Participants under PV \<5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a dose of approximately 55 mg/m\^2 (60 to 120 mg based on BSA) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
Selinexor 60mg (PV<5) (Equivalent to 35 mg/m^2)
n=27 participants at risk
Participants under PV \<5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a fixed dose of 60 mg (equivalent to 35 mg/m\^2), based on BSA, twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
Selinexor 60mg (PV >=5) (Equivalent to 35 mg/m^2)
n=115 participants at risk
Participants under PV \>=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m\^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).
Physician's Choice 1 (PV <5)
n=39 participants at risk
Participants under PV \< 5.0 (those who had one prior line of AML therapy) received Best Supportive Care (BSC) which included blood product transfusions, antimicrobials, growth factors as needed, and hydroxyurea.
Physician's Choice 2 (PV >=5)
n=45 participants at risk
Participants under PV \>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Gastrointestinal disorders
Nausea
57.7%
41/71 • Number of events 41 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
59.3%
16/27 • Number of events 16 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
59.1%
68/115 • Number of events 68 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
33.3%
13/39 • Number of events 13 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
17.8%
8/45 • Number of events 8 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Diarrhoea
23.9%
17/71 • Number of events 17 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
48.1%
13/27 • Number of events 13 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
35.7%
41/115 • Number of events 41 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
20.5%
8/39 • Number of events 8 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
13.3%
6/45 • Number of events 6 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Constipation
28.2%
20/71 • Number of events 20 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
29.6%
8/27 • Number of events 8 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
21.7%
25/115 • Number of events 25 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
41.0%
16/39 • Number of events 16 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
33.3%
15/45 • Number of events 15 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Vomiting
26.8%
19/71 • Number of events 19 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
37.0%
10/27 • Number of events 10 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
26.1%
30/115 • Number of events 30 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
17.9%
7/39 • Number of events 7 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
13.3%
6/45 • Number of events 6 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Stomatitis
11.3%
8/71 • Number of events 8 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.0%
8/115 • Number of events 8 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.7%
3/39 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.7%
3/45 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Abdominal Pain
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
10.4%
12/115 • Number of events 12 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
13.3%
6/45 • Number of events 6 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Abdominal Pain Upper
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.2%
6/115 • Number of events 6 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Dyspepsia
4.2%
3/71 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Gingival Bleeding
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.1%
7/115 • Number of events 7 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Haemorrhoids
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.7%
3/45 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Aphthous Ulcer
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Mouth Haemorrhage
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.5%
4/115 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Abdominal Discomfort
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Gingival Pain
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Odynophagia
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Toothache
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Dry Mouth
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
4.2%
3/71 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Dysphagia
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Flatulence
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Melaena
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Oral Pain
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Abdominal Pain Lower
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Anal Fissure
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Angina Bullosa Haemorrhagica
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Enterocolitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Eructation
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Gastritis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Gastrointestinal Haemorrhage
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Mouth Ulceration
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Oral Disorder
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Oral Mucosa Haematoma
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Oral Mucosal Blistering
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Abdominal Tenderness
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Anal Incontinence
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Breath Odour
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Diverticulum
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Faeces Soft
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Gastrointestinal Pain
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Gingival Hypertrophy
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Glossitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Ileus
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Inguinal Hernia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Lip Blister
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Lip Dry
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Lip Oedema
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Lip Pain
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Lip Swelling
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Lip Ulceration
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Mouth Swelling
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Oesophagitis
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Oral Contusion
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Oral Dysaesthesia
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Palatal Disorder
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Perianal Erythema
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Proctalgia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Rectal Fissure
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Rectal Haemorrhage
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Retching
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Salivary Hypersecretion
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Tongue Haematoma
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Tongue Ulceration
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Tooth Loss
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Gastrointestinal disorders
Trichoglossia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Fatigue
46.5%
33/71 • Number of events 33 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
48.1%
13/27 • Number of events 13 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
43.5%
50/115 • Number of events 50 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
38.5%
15/39 • Number of events 15 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
28.9%
13/45 • Number of events 13 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Pyrexia
11.3%
8/71 • Number of events 8 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
18.5%
5/27 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
24.3%
28/115 • Number of events 28 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
33.3%
13/39 • Number of events 13 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
28.9%
13/45 • Number of events 13 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Oedema Peripheral
23.9%
17/71 • Number of events 17 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
18.5%
5/27 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
18.3%
21/115 • Number of events 21 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
25.6%
10/39 • Number of events 10 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
11.1%
5/45 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Asthenia
23.9%
17/71 • Number of events 17 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
22.2%
6/27 • Number of events 6 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
19.1%
22/115 • Number of events 22 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
12.8%
5/39 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
11.1%
5/45 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Malaise
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.0%
8/115 • Number of events 8 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.7%
3/39 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Oedema
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.3%
5/115 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
10.3%
4/39 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Chills
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.3%
5/115 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.7%
3/39 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Mucosal Inflammation
4.2%
3/71 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
10.3%
4/39 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.7%
3/45 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Pain
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.1%
7/115 • Number of events 7 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Gait Disturbance
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
General Physical Health Deterioration
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Injection Site Bruising
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Non-Cardiac Chest Pain
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Ulcer
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Catheter Site Haemorrhage
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Face Oedema
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Generalised Oedema
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Secretion Discharge
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Catheter Site Haematoma
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Chest Pain
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Drug Intolerance
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Extravasation
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Feeling Cold
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Granuloma
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Hernia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Impaired Healing
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Infusion Site Haemorrhage
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Injection Site Discolouration
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Injection Site Pain
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Mucosal Dryness
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Nodule
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Peripheral Swelling
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Swelling
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
General disorders
Decreased Appetite
57.7%
41/71 • Number of events 41 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
44.4%
12/27 • Number of events 12 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
53.0%
61/115 • Number of events 61 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
23.1%
9/39 • Number of events 9 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
15.6%
7/45 • Number of events 7 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hyponatraemia
36.6%
26/71 • Number of events 26 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
22.2%
6/27 • Number of events 6 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
21.7%
25/115 • Number of events 25 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.7%
3/39 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hypokalaemia
14.1%
10/71 • Number of events 10 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.8%
9/115 • Number of events 9 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
12.8%
5/39 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
13.3%
6/45 • Number of events 6 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hypocalcaemia
7.0%
5/71 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
9.6%
11/115 • Number of events 11 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
8.9%
4/45 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hypercreatininaemia
7.0%
5/71 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
11.3%
13/115 • Number of events 13 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hypomagnesaemia
9.9%
7/71 • Number of events 7 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.8%
9/115 • Number of events 9 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.7%
3/45 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hyperglycaemia
8.5%
6/71 • Number of events 6 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
11.1%
3/27 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.1%
7/115 • Number of events 7 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.7%
3/45 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hyperkalaemia
11.3%
8/71 • Number of events 8 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.8%
9/115 • Number of events 9 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Dehydration
11.3%
8/71 • Number of events 8 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.2%
6/115 • Number of events 6 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.7%
3/39 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hypophosphataemia
12.7%
9/71 • Number of events 9 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.3%
5/115 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hyperuricaemia
7.0%
5/71 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hypoalbuminaemia
5.6%
4/71 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hypercalcaemia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.5%
4/115 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hypermagnesaemia
4.2%
3/71 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Cachexia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hyperlipasaemia
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hyperphosphataemia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hypoglycaemia
4.2%
3/71 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Fluid Retention
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hyperamylasaemia
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Fluid Overload
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Tumour Lysis Syndrome
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Diabetes Mellitus
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Failure To Thrive
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Gout
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hyperglycaemic Hyperosmolar Nonketotic Syndrome
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hyperhomocysteinaemia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hypernatraemia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Hypouricaemia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Metabolic Acidosis
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Metabolism and nutrition disorders
Polydipsia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Blood and lymphatic system disorders
Thrombocytopenia
40.8%
29/71 • Number of events 29 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
25.9%
7/27 • Number of events 7 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
33.0%
38/115 • Number of events 38 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
46.2%
18/39 • Number of events 18 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
24.4%
11/45 • Number of events 11 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Blood and lymphatic system disorders
Anaemia
28.2%
20/71 • Number of events 20 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
25.9%
7/27 • Number of events 7 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
25.2%
29/115 • Number of events 29 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
43.6%
17/39 • Number of events 17 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
22.2%
10/45 • Number of events 10 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Blood and lymphatic system disorders
Neutropenia
8.5%
6/71 • Number of events 6 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
18.5%
5/27 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
14.8%
17/115 • Number of events 17 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
25.6%
10/39 • Number of events 10 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
20.0%
9/45 • Number of events 9 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Blood and lymphatic system disorders
Leukopenia
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
11.1%
3/27 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
8.7%
10/115 • Number of events 10 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
12.8%
5/39 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
8.9%
4/45 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Blood and lymphatic system disorders
Febrile Neutropenia
12.7%
9/71 • Number of events 9 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.1%
7/115 • Number of events 7 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.7%
3/39 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Blood and lymphatic system disorders
Leukocytosis
8.5%
6/71 • Number of events 6 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.2%
6/115 • Number of events 6 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
10.3%
4/39 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Blood and lymphatic system disorders
Lymphopenia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Blood and lymphatic system disorders
Pancytopenia
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Blood and lymphatic system disorders
Coagulopathy
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Blood and lymphatic system disorders
Lymphadenopathy
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Blood and lymphatic system disorders
Increased Tendency To Bruise
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Blood and lymphatic system disorders
Polycythaemia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Blood and lymphatic system disorders
Splenomegaly
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Blood and lymphatic system disorders
Thrombocytosis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
19.7%
14/71 • Number of events 14 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
18.5%
5/27 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
20.9%
24/115 • Number of events 24 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
20.5%
8/39 • Number of events 8 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
22.2%
10/45 • Number of events 10 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Epistaxis
18.3%
13/71 • Number of events 13 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
11.1%
3/27 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
21.7%
25/115 • Number of events 25 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
17.9%
7/39 • Number of events 7 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
15.6%
7/45 • Number of events 7 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Cough
16.9%
12/71 • Number of events 12 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
11.1%
3/27 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
13.0%
15/115 • Number of events 15 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
12.8%
5/39 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
17.8%
8/45 • Number of events 8 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
4.2%
3/71 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.7%
3/45 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Productive Cough
5.6%
4/71 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.7%
3/39 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.7%
3/45 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.5%
4/115 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.5%
4/115 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Hypoxia
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Wheezing
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Atelectasis
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Hiccups
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Sinus Pain
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Upper-Airway Cough Syndrome
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Dysphonia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Laryngeal Pain
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Lung Consolidation
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Nasal Inflammation
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Paranasal Sinus Discomfort
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Pharyngeal Inflammation
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Rales
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Rhonchi
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Sinus Disorder
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Tachypnoea
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Tonsillar Erythema
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Respiratory, thoracic and mediastinal disorders
Tonsillar Hypertrophy
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Urinary Tract Infection
8.5%
6/71 • Number of events 6 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.8%
9/115 • Number of events 9 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
12.8%
5/39 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Oral Herpes
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
10.3%
4/39 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
8.9%
4/45 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Nasopharyngitis
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.3%
5/115 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.7%
3/45 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Oral Candidiasis
5.6%
4/71 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.5%
4/115 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Pneumonia
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.5%
4/115 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.7%
3/39 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Cellulitis
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Lung Infection
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Sinusitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Upper Respiratory Tract Infection
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Device Related Infection
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Periodontitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Pneumonia Fungal
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.7%
3/45 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Sepsis
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Candida Infection
4.2%
3/71 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Folliculitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Oesophageal Candidiasis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Skin Infection
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Staphylococcal Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Clostridium Difficile Colitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Clostridium Difficile Infection
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Conjunctivitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Ear Infection
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Fungal Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Herpes Dermatitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Lip Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Nasal Herpes
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Pharyngitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Pseudomonas Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Rash Pustular
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Rhinovirus Infection
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Soft Tissue Infection
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Abscess Limb
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Acute Sinusitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Anal Abscess
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Aspergillus Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Asymptomatic Bacteriuria
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Bacterial Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Bacteriuria
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Bronchitis
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Catheter Site Cellulitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Clostridium Colitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Dermo-Hypodermitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Diverticulitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Empyema
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Encephalitis
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Enterobiasis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Enterococcal Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Furuncle
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Genital Herpes
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Gingivitis
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Groin Infection
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Herpes Simplex
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Herpes Zoster
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Infected Dermal Cyst
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Influenza
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Lower Respiratory Tract Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Lymph Gland Infection
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Meningitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Metapneumovirus Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Mucosal Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Oesophageal Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Ophthalmic Herpes Simplex
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Oral Fungal Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Oral Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Osteomyelitis
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Parotitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Pneumonia Klebsiella
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Proteus Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Pseudomembranous Colitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Respiratory Tract Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Rhinitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Septic Shock
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Sialoadenitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Staphylococcal Bacteraemia
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Stenotrophomonas Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Tonsillitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Tonsillitis Bacterial
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Tooth Abscess
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Tooth Infection
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Varicella Zoster Virus Infection
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Dysgeusia
9.9%
7/71 • Number of events 7 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
11.1%
3/27 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
10.4%
12/115 • Number of events 12 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.7%
3/39 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Headache
7.0%
5/71 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
11.1%
3/27 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
17.9%
7/39 • Number of events 7 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
13.3%
6/45 • Number of events 6 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Syncope
4.2%
3/71 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.3%
5/115 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Dizziness
16.9%
12/71 • Number of events 12 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
15.7%
18/115 • Number of events 18 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
20.5%
8/39 • Number of events 8 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Presyncope
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
11.1%
3/27 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Somnolence
5.6%
4/71 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Ageusia
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Balance Disorder
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Memory Impairment
4.2%
3/71 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Ataxia
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Lethargy
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Polyneuropathy
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Tremor
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Aphasia
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Cognitive Disorder
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Dysarthria
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Neuropathy Peripheral
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Paraesthesia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Speech Disorder
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Aphonia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Cogwheel Rigidity
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Coordination Abnormal
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Drooling
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Dysaesthesia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Encephalopathy
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Haemorrhage Intracranial
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Hemianopia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Hemianopia Homonymous
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Hypersomnia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Hypoaesthesia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Hyposmia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Migraine
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Parosmia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Peripheral Sensory Neuropathy
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Sensory Loss
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Nervous system disorders
Synaesthesia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Weight Decreased
21.1%
15/71 • Number of events 15 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
14.8%
4/27 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
17.4%
20/115 • Number of events 20 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.7%
3/39 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.7%
3/45 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Alanine Aminotransferase Increased
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.3%
5/115 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Aspartate Aminotransferase Increased
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.3%
5/115 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
International Normalised Ratio Increased
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.5%
4/115 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.7%
3/39 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Weight Increased
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
15.4%
6/39 • Number of events 6 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Blood Lactate Dehydrogenase Increased
7.0%
5/71 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Blood Alkaline Phosphatase Increased
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
C-Reactive Protein Increased
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Blood Uric Acid Increased
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Electrocardiogram Qt Prolonged
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Activated Partial Thromboplastin Time Prolonged
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Blood Creatine Phosphokinase Increased
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Blood Thyroid Stimulating Hormone Increased
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
General Physical Condition Abnormal
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Blood Creatine Phosphokinase Decreased
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Blood Pressure Decreased
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Blood Urea Increased
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Cardiac Murmur
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Ejection Fraction Decreased
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Electrocardiogram Change
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Hypophonesis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Oxygen Saturation Decreased
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Transaminases Increased
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Alpha 1 Foetoprotein Increased
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Astrovirus Test Positive
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Bilirubin Urine
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Blast Cell Count Increased
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Bleeding Time Prolonged
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Blood Alkaline Phosphatase Decreased
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Blood Lactic Acid Increased
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Blood Test Abnormal
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Body Temperature Increased
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Gamma-Glutamyltransferase Increased
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Glomerular Filtration Rate Decreased
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Liver Function Test Increased
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
Prothrombin Time Prolonged
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
White Blood Cell Count
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Investigations
White Blood Cell Count Increased
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Night Sweats
11.3%
8/71 • Number of events 8 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
11.1%
3/27 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
8.7%
10/115 • Number of events 10 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
8.9%
4/45 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Petechiae
5.6%
4/71 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
17.9%
7/39 • Number of events 7 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
13.3%
6/45 • Number of events 6 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Hyperhidrosis
8.5%
6/71 • Number of events 6 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Rash
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
10.3%
4/39 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Ecchymosis
4.2%
3/71 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Pruritus
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Skin Lesion
4.2%
3/71 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Skin Ulcer
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Alopecia
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Decubitus Ulcer
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Cold Sweat
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Dermatitis
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Purpura
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Skin Mass
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Swelling Face
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Dermal Cyst
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Dermatitis Bullous
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Dry Skin
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Facial Wasting
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Macule
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Miliaria
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Nail Disorder
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Rash Erythematous
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Rash Pruritic
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Skin Discolouration
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Skin Induration
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Skin Maceration
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Skin and subcutaneous tissue disorders
Urticaria
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Psychiatric disorders
Insomnia
14.1%
10/71 • Number of events 10 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
14.8%
4/27 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.1%
7/115 • Number of events 7 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
10.3%
4/39 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.7%
3/45 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Psychiatric disorders
Confusional State
7.0%
5/71 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.0%
8/115 • Number of events 8 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.7%
3/45 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Psychiatric disorders
Anxiety
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.5%
4/115 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Psychiatric disorders
Depression
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.7%
3/39 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Psychiatric disorders
Agitation
8.5%
6/71 • Number of events 6 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Hallucination
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Personality Change
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Psychiatric disorders
Restlessness
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Psychiatric disorders
Abnormal Dreams
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Psychiatric disorders
Bulimia Nervosa
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Psychiatric disorders
Delirium
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Psychiatric disorders
Disorientation
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Psychiatric disorders
Flat Affect
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Psychiatric disorders
Hallucination, Visual
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Psychiatric disorders
Irritability
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Psychiatric disorders
Listless
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Psychiatric disorders
Mental Disorder
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Psychiatric disorders
Mental Status Changes
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Psychiatric disorders
Nervousness
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Psychiatric disorders
Psychomotor Retardation
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Arthralgia
7.0%
5/71 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.2%
6/115 • Number of events 6 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
12.8%
5/39 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Back Pain
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.2%
6/115 • Number of events 6 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
12.8%
5/39 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
11.1%
5/45 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Muscular Weakness
7.0%
5/71 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.5%
4/115 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.7%
3/39 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Pain In Extremity
5.6%
4/71 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Muscle Spasms
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.7%
3/45 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Bone Pain
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.3%
5/115 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Myalgia
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Neck Pain
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Flank Pain
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Joint Swelling
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Pain In Jaw
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Bursitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Groin Pain
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Ligament Pain
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Limb Discomfort
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Limb Mass
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Muscle Mass
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Muscle Tightness
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Muscle Twitching
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Osteitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Musculoskeletal and connective tissue disorders
Torticollis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Hypotension
8.5%
6/71 • Number of events 6 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
9.6%
11/115 • Number of events 11 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
10.3%
4/39 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Haematoma
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.3%
5/115 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
17.9%
7/39 • Number of events 7 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Hypertension
5.6%
4/71 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Pallor
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Haemorrhage
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Phlebitis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.7%
3/39 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Thrombophlebitis
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Orthostatic Hypotension
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Deep Vein Thrombosis
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Flushing
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Circulatory Collapse
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Embolism
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Hot Flush
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Intermittent Claudication
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Lymphoedema
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Poor Peripheral Circulation
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Thrombophlebitis Superficial
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Vascular disorders
Venous Thrombosis
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Acute Kidney Injury
11.3%
8/71 • Number of events 8 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.7%
3/45 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Haematuria
4.2%
3/71 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
11.1%
3/27 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
6.7%
3/45 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Pollakiuria
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Proteinuria
4.2%
3/71 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Dysuria
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Renal Failure
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Urinary Incontinence
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Urinary Retention
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Bladder Dilatation
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Chronic Kidney Disease
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Micturition Urgency
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Bladder Pain
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Chromaturia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Incontinence
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Nocturia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Polyuria
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Urethral Caruncle
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Urethral Haemorrhage
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Urge Incontinence
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Urinary Tract Obstruction
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Renal and urinary disorders
Urinary Tract Pain
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Eye disorders
Vision Blurred
11.3%
8/71 • Number of events 8 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.8%
9/115 • Number of events 9 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Eye disorders
Visual Impairment
5.6%
4/71 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Eye disorders
Cataract
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Eye disorders
Dry Eye
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Eye disorders
Visual Acuity Reduced
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Eye disorders
Conjunctival Haemorrhage
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Eye disorders
Eye Pain
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Eye disorders
Lacrimation Increased
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Eye disorders
Eye Haemorrhage
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Eye disorders
Eyelid Oedema
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Eye disorders
Ocular Hyperaemia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Eye disorders
Periorbital Oedema
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Eye disorders
Photopsia
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Eye disorders
Retinal Haemorrhage
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Eye disorders
Diplopia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Eye disorders
Eye Inflammation
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Eye disorders
Eye Swelling
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Eye disorders
Eyelid Ptosis
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Eye disorders
Vitreous Floaters
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Eye disorders
Vitreous Haemorrhage
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Fall
8.5%
6/71 • Number of events 6 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.8%
9/115 • Number of events 9 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Contusion
7.0%
5/71 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.3%
5/115 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.7%
3/39 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Infusion Related Reaction
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Laceration
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Procedural Pain
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Skin Abrasion
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Transfusion Reaction
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Allergic Transfusion Reaction
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Animal Bite
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Infections and infestations
Facial Bones Fracture
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Head Injury
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Joint Injury
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Overdose
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Periorbital Haematoma
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Post Procedural Contusion
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Sunburn
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Tooth Fracture
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Injury, poisoning and procedural complications
Wound
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Tachycardia
7.0%
5/71 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.5%
4/115 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.4%
2/45 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Sinus Tachycardia
5.6%
4/71 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Atrial Fibrillation
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
5.1%
2/39 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Bradycardia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Acute Left Ventricular Failure
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Angina Pectoris
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Arrhythmia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Bundle Branch Block Right
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Cardiac Failure
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Cardiac Flutter
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Extrasystoles
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Palpitations
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Sinus Bradycardia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Supraventricular Tachycardia
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Cardiac disorders
Tachycardia Paroxysmal
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Ear and labyrinth disorders
Deafness
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Ear and labyrinth disorders
Ear Discomfort
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
7.4%
2/27 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
1.7%
2/115 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Ear and labyrinth disorders
Vertigo
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
3/115 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Ear and labyrinth disorders
Ear Pain
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Ear and labyrinth disorders
Tinnitus
4.2%
3/71 • Number of events 3 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Ear and labyrinth disorders
Ear Congestion
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Ear and labyrinth disorders
Eustachian Tube Dysfunction
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Ear and labyrinth disorders
Excessive Cerumen Production
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Ear and labyrinth disorders
Hypoacusis
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Hepatobiliary disorders
Hyperbilirubinaemia
2.8%
2/71 • Number of events 2 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
4.3%
5/115 • Number of events 5 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Hepatobiliary disorders
Cholelithiasis
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Hepatobiliary disorders
Hepatomegaly
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Hepatobiliary disorders
Jaundice
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Hepatobiliary disorders
Ocular Icterus
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Endocrine disorders
Hypothyroidism
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.5%
4/115 • Number of events 4 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Endocrine disorders
Cushingoid
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Endocrine disorders
Hyperthyroidism
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
3.7%
1/27 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Reproductive system and breast disorders
Breast Pain
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Reproductive system and breast disorders
Breast Swelling
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Reproductive system and breast disorders
Gynaecomastia
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Reproductive system and breast disorders
Nipple Pain
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Reproductive system and breast disorders
Oedema Genital
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Reproductive system and breast disorders
Ovarian Cyst
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Reproductive system and breast disorders
Testicular Oedema
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Reproductive system and breast disorders
Vaginal Haemorrhage
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
1.4%
1/71 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chloroma
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.2%
1/45 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemic Infiltration
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/115 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
2.6%
1/39 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Immune system disorders
Hypersensitivity
0.00%
0/71 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/27 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.87%
1/115 • Number of events 1 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/39 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
0.00%
0/45 • From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.

Additional Information

Jatin Shah, MD

Karyopharm Therapeutics Inc.

Phone: (617) 658-0600

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: OTHER